Humira: Will AbbVie's Patents Keep Out Biosimilars For Its TNF-Blocker Blockbuster?
Markman Advisors • 21 Comments
Markman Advisors • 21 Comments
Tue, Jul. 19, 10:50 AM
- Prompted by moderating growth from traditional drug sales, large cap drug/biotech firms have their sights set on developers of cancer therapies, in particular immunotherapies, to boost both their top and bottom lines. Roche (OTCQX:RHHBY -1.5%), Amgen (AMGN +0.1%), Sanofi (SNY -1.3%) and Gilead Sciences (GILD -1.2%) are all actively on the prowl for acquisitions.
- Medivation (MDVN +0.1%), with its prostate cancer drug Xtandi (enzalutamide), is currently in play. Sanofi has been the most aggressive with two unsuccessful bids, but Pfizer (PFE) and Celgene (CELG -0.6%) are supposedly interested.
- Analysts say Incyte (INCY -0.4%), with polycythemia vera and myelofibrosis drug Jakafi (ruxolitinib), and Seattle Genetics (SGEN -0.8%), with lymphoma drug Adcetris (brentuximab vedotin), are the most attractive takeover targets.
- Recent transactions include AbbVie's (ABBV -0.3%) buyout of Stemcentryx, Jazz Pharmaceuticals' (JAZZ -0.8%) takeout of Celator Pharmaceuticals and Bristol-Myers Squibb's (BMY -0.2%) acquisition of Cormorant Pharmaceuticals.
Mon, Jul. 11, 12:30 PM
Wed, May 25, 9:00 AM
- According to Bloomberg, Celgene (NASDAQ:CELG) is considering a bid for Medivation (NASDAQ:MDVN), currently trying to hold off Sanofi (NYSE:SNY). Other suitors supposedly in the mix are Pfizer (NYSE:PFE), AstraZeneca (NYSE:AZN) and Amgen (NASDAQ:AMGN).
- Sanofi is trying to replace Medivation's board after it rejected its per-share offer of $52.50.
- Previously: Amgen another possible Medivation suitor (May 5)
Thu, May 5, 11:38 AM| Thu, May 5, 11:38 AM | 11 Comments
Sep. 16, 2015, 9:50 AM
- Amgen (NASDAQ:AMGN) acquires Naarden, The Netherlands-based Dezima Pharma for $300M in cash and up to $1.25B in development- and sales-related milestones.
- Privately-held Dezima, founded in 2012, develops treatments for dyslipidemia. Its lead program is DEZ-001, a cholesteryl ester transfer protein that has shown efficacy in lowering LDL-C levels (bad cholesterol). According to the company, it is a potential rival to PCSK9 inhibitors because of its comparable effect on lowering LDL-C and its beneficial effect on cholesterol efflux, which is the capacity of the plasma to remove toxic cholesterol from the plaque in the coronary arteries.
- In a recent Phase 2b study, called TULIP, 5 mg of DEZ-001 (formerly TA-8995), lowered LDL-C by 45% and increased HDL-C by 161%. 10 mg of DEZ-001, in combination with statin therapy, reduced LDL-C by an additional 48%. Almost all patients on the combo regimen achieved the LDL-C target of <1.8 mmol/L, a more stringent metric than the historical target of 2.6 mmol/L. DEZ-001 also significantly boosted cholesterol efflux while being safe and well-tolerated.
Jul. 28, 2015, 2:38 AM
- So what's Allergan (NYSE:AGN) doing with all that cash from the Teva deal? CEO Brent Saunders plans to use the money to increase the size of the firm's existing drug business, expand into new therapy areas and pursue larger deals.
- When asked if Allergan planned to spend the cash within 18 months, Saunders replied that he would, as long as the company could maintain its investment-grade credit rating.
- Possible targets: Biogen (NASDAQ:BIIB), AbbVie (NYSE:ABBV) and Amgen (NASDAQ:AMGN).
- Previously: Teva to buy Allergan Generics for $40.5B (Jul. 27 2015)
Mar. 5, 2015, 8:52 AM
- AbbVie's (NYSE:ABBV) extraordinarily generous buyout of Pharmacyclics (NASDAQ:PCYC) is a crystal clear example of how keen big pharma is to boost its prospects with biotech drugs with blockbuster potential. The transaction's $20B tab, backing out PCYC's $1B cash balance, values Imbruvica (ibrutinib) at $40B since Pharmacyclics' commercial partner Johnson & Johnson (NYSE:JNJ) gets 50% of Imbruvica's revenue. This implies a multiple of almost 7x Imbruvica's projected peak sales of $6B. By comparison, Amgen's (NASDAQ:AMGN) takeout of Onyx Pharma and Sanofi's (NYSE:SNY) takeout of Genzyme were both at 5x premiums.
- The looming patent expiration for Humira ($12.5B in sales the past four quarters) undoubtedly provided AbbVie extra incentive to get the deal done.
- Adding 50% of Imbruvica's sales to AbbVie's top line should increase its revenue growth 3 - 7% and EPS growth 8 - 11% through 2020.
- According to RBC analyst Michael Yee, other biotechs on the big ticket acquisition radar are: BioMarin Pharmaceuticals (NASDAQ:BMRN), Dyax (NASDAQ:DYAX), Esperion Therapeutics (NASDAQ:ESPR), United Therapeutics (NASDAQ:UTHR), Vertex Pharmaceuticals (NASDAQ:VRTX), Intercept Pharmaceuticals (NASDAQ:ICPT), Juno Therapeutics (NASDAQ:JUNO), Kite Pharma (NASDAQ:KITE), PTC Therapeutics (NASDAQ:PTCT) and Receptos (NASDAQ:RCPT).
May 22, 2014, 7:44 AM
- Roman Abramovich's investment company, Millhouse LLC and OAO Pharmstandard buy a majority share of Russian biosimilar manufacturer Biocad. Millhouse will own 50%, Pharmstandard 20% and Biocad founder and CEO Dmitry Morozov will own 30%. The purchase price is undisclosed but the firm is valued at ~$1B according to a source close to the matter.
- Pfizer (PFE) and Amgen (AMGN) reportedly had interest in the firm.
- Biocad is currently recruiting patients for clinical studies of copies of Roche's (RHHBY) Rituxan, Herceptin and Avastin. The firm also cancer chemotherapies, a drug for genital infections and three drugs for viral infections.
Aug. 28, 2013, 6:50 PM
- Fitch follows Moody's lead, lowering its outlook on Amgen (AMGN) to negative from stable on the back of its recent deal to buy Onyx Pharmaceuticals (ONXX) for around $10.4B in cash.
- Fitch says AMGN's leverage is going to increase significantly because of the acquisition, by at least $8B.
- To pay for the deal, AMGN is taking out $8.1B of five-year loans and paying an average interest rate 104 basis points above the three-month London Interbank Offered Rate - despite the fact that it's sitting on $22B in cash.
- Why? Because of a quirk in the U.S. tax system in which companies' foreign earnings are taxable in the U.S., but only once they are repatriated to the parent.
- Companies sitting on large amounts of cash can cut their tax bills by keeping income offshore in lower-tax countries. As a result, American companies - like Amgen - are holding a lot of cash offshore, but cash poor at home - which in AMGN's case leads to higher leverage and lower credit ratings.
Aug. 26, 2013, 3:23 AM
- Amgen (AMGN) is paying $10.4B, or $9.7B excluding Onyx's (ONXX) cash, making it the fifth-largest biotechnology deal in history. The $125-a-share offer represents a 4.2% increase from Amgen's $120 bid in June. Onyx closed at $116.96 on Friday.
- By buying Onyx, Amgen is gaining full rights to Kyprolis, a potential blockbuster treatment for multiple myeloma, revenue from liver and kidney cancer drug Nexavar, royalties on Bayer's colon cancer medicine Stivarga, and prospective future payments on a breast cancer drug that Pfizer is developing.
- The deal comes as safety fears have hit sales of Amgen's flagship anemia drugs, Aranesp and Epogen, and ahead of a patent cliff starting in 2015 in which four of the company's five top-selling products are due to lose patent protection. (PR)
Aug. 25, 2013, 5:52 PM
Aug. 24, 2013, 3:54 PM
- The paper adds a deal could be "announced as soon as Monday," but cautions "talks are ongoing and could still fall apart."
- The reported price would represent a 7% premium to Onyx's (ONXX) Friday close of $116.96.
- Amgen (AMGN) reportedly revised its bid from a prior $130/share after failing to obtain trial data related to Onyx's Kyprolis blood-cancer drug. The company is still paying a steep 10.5x 2014E sales.
- More on Amgen/Onyx
- Update: The WSJ also reports a $125/share deal is close. Its sources think a deal "is likely to be announced Monday, if not sooner."
Aug. 23, 2013, 11:38 AM
- It looks like Amgen (AMGN -1%) is in fact pushing for a price tag lower than the $130 a share it offered this month for Onyx Pharmaceuticals (ONXX -0.4%).
- The spat over access to trial data on Kyrpolis looks like it hasn't been resolved. Reports earlier this week suggested that the dispute over access to data on Kyprolis had been taken care of, with ONXX agreeing to provide the information. However, ONXX has apparently balked, saying the data pertains to sensitive patient data.
- Amgen hasn't put a new offer on the table yet and is considering its next move.
Aug. 22, 2013, 3:01 PM
- Amgen (AMGN +1.7%) may be pushing for a lower price in its prospective bid for Onyx (ONXX +1.7%) according to people familiar with the matter, Bloomberg's Meg Tirrell says.
- Many assumed the deal would get done at $130/ share until a dispute over Kyprolis data derailed the process.
- ONXX has since given AMGN (and others apparently) access to the data.
Aug. 22, 2013, 3:02 AM
- Onyx Pharmaceuticals (ONXX) has reportedly provided data from the Phase III trial of its blood-cancer drug Kyprolis to Amgen (AMGN) and other potential acquirers, removing a stumbling block that had caused talks to stall.
- Amgen is in advanced negotiations to buy Onyx for $9.5B and had asked for the information to better assess the medicine, which is seen as a potential blockbuster, while AstraZeneca (AZN) has also held discussions about a deal.
- Onyx had been reluctant to provide the data, as the trial of Kyprolis is still ongoing.
Aug. 19, 2013, 3:24 PM
- With each passing day, the market seems to get more nervous about the prospects for a deal between Onyx Pharmaceuticals (ONXX -4.6%) and Amgen (AMGN -0.3%).
- ONXX shares are off substantially on the session as speculation continues to swirl surrounding a rumored disagreement between the two firms regarding Kyprolis trial data.
- ISI's Mark Schoenebaum is out with new commentary on the proposed deal, saying AMGN may now exercise a bit more discipline regarding price and due diligence.
- Nevertheless, a deal is more likely than not despite the abundance of what Schoenebaum calls "posturing."